Treats edema. ANDA 205473, held by Ph Health. Ethacrynate Sodium.
As of Nov 15, 2026, ANDA 205473 (Ethacrynate Sodium), held by Ph Health, was first approved by FDA on Jul 29, 2015, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Ethacrynate sodium is indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required. 1. Treatment of the edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. 2. Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema. 3. Short-term management of hospitalized pediatric patients, other than infants, with congenital heart disease or the nephrotic syndrome. 4. Intravenous ethacrynate sodium is indicated when a rapid onset of diuresis is desired, e.g.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 29, 2015 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ethacrynate SodiumEQ 50MG BASE/VIAL · injectable;injection | Ethacrynate Sodium | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
